NCT03048487

Brief Summary

A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. Data will be collected for up to 7 days of ICU stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

October 4, 2016

Last Update Submit

November 2, 2018

Conditions

Critical IllnessDietary Modification

Outcome Measures

Primary Outcomes (1)

  • Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)

    Daily up to 7 days of ICU stay

Secondary Outcomes (29)

  • Enteral formula utilized (Standard, High protein, Very high protein)

    Daily up to 7 days of ICU stay

  • Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)

    Daily up to 7 days of ICU stay

  • Estimated caloric needs (Kcal/day)

    Daily up to 7 days of ICU stay

  • Method for estimating caloric needs (descriptive name of scale) calorie needs met.

    Daily up to 7 days of ICU stay

  • Percentage of daily caloric needs met (%) calorie needs met.

    Daily up to 7 days of ICU stay

  • +24 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.

You may qualify if:

  • Adult patients (age ≥18 years)
  • Admitted to the ICU
  • Administered at least one dose of enteral formula

You may not qualify if:

  • Receiving exclusive oral or exclusive parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Community Medical Center, Scranton, PA

Scranton, Pennsylvania, 18510, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Layon, MD, FACP

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

February 9, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)